Smart Capsule for Automatic Adherence Monitoring

Status Completed

Clinical Trial Summary

In pharmacotherapy trials in drug-dependent populations, medication compliance is a significant issue, as rates tend to be low and adherence to medication may predict improved outcomes (Baros et al, 2007; McRae et al, 2004; O'Brien et al, 1996; Somoza et al., 2010). However, methods commonly used to determine compliance may result in inaccurate measurement of adherence. It is therefore essential to develop measurement systems that not only accurately and objectively measure compliance, but can also have the potential to increase compliance in difficult to treat disorders such as addiction. In this study, we propose to assess the acceptability, tolerability, and efficacy of the ID-Cap System, a novel compliance measurement device, in a healthy population.

Clinical Trial Description

The primary objective of the clinical trial is to evaluate the acceptability, tolerability, and efficacy of the ID-Cap System in a healthy population.

Participation in the study takes 10 visits over a period of approximately five weeks. The first visit is a screening visit to determine if participants are eligible to participate. After inclusion into the study, participants will be randomized into one of three groups. Participants randomized to Group 1 will have compliance measured by patient reports, pill count, and riboflavin measurement. Participants randomized to Group 2 will have compliance measured by patient reports, pill count, riboflavin measurement, and data collected by the e-Tect reader. Participants randomized to Group 3 will also have compliance measured by patient reports, pill count, riboflavin measurement, and data collected by the ID-Cap reader. However, participants randomized to this group will also receive reminder calls and/or text messages to ingest the study medication if a signal is not sent from the ID-Cap reader to the study team within one hour of the scheduled medication administration time.

After the initial screening visit, participants will present to the clinic twice weekly to complete self-reports of compliance, provide urine samples for riboflavin assessment, and be assessed for adverse effects.

They will also be asked to attend one follow-up visit to include abdominal x-ray in order to confirm passage of the capsules. ;

Study Design

Related Conditions & MeSH terms

Medication Adherence

Clinical Trial Details

NCT number	NCT02344238
Study type	Interventional
Source	Medical University of South Carolina
Contact
Status	Completed
Phase	N/A
Start date	July 2015
Completion date	June 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04709640` - Pilot Study to Improve Medication Management in Older Adults	N/A
Completed	`NCT03257579` - Myocardial Infarction Prescription Duration Adherence Study	N/A
Completed	`NCT05376397` - Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)	N/A
Withdrawn	`NCT03427008` - A Pilot Study of mDOT for Immunosuppressant Adherence in Adult Kidney Transplant Recipients	N/A
Completed	`NCT03805451` - Life Steps for PrEP for Youth	N/A
Withdrawn	`NCT03292393` - Social Norms and Antihypertensive Medication Adherence	N/A
Completed	`NCT02823795` - The Supporting Patient Activation in Transition to Home Intervention	N/A
Not yet recruiting	`NCT02876848` - A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)	N/A
Completed	`NCT02914730` - Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections
Completed	`NCT02797262` - Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System	N/A
Completed	`NCT02066935` - Non-adherence to Immunosuppressives in Kidney Transplantation in Brazil Multicenter Study
Completed	`NCT01934608` - The Effect of Synching Prescription Refills on Adherence	N/A
Completed	`NCT01770314` - Study to Test the Efficacy of Online Education to Increase Safe Use of Opioid Medication.	Phase 2
Completed	`NCT01741311` - Secondary HIV Prevention and Adherence Among HIV-infected Drug Users	N/A
Recruiting	`NCT01105104` - An Enhanced Medication Monitoring Program	Phase 1
Completed	`NCT01859273` - Adherence Enhancement for Renal Transplant Patients	N/A
Withdrawn	`NCT01430702` - Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults	N/A
Completed	`NCT01118208` - Blister Packaging Medication to Increase Treatment Adherence and Clinical Response	N/A
Completed	`NCT00848224` - Improving Adherence to Pharmacological Treatment	N/A
Completed	`NCT06034301` - Pill Bottle vs Reminder App	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.